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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

In an interview this weekend with Biocentury TV, four employees of the Office of Hematology and Oncology Products (OHOP) sat down to provide insight in to the office, tips for regulatory professionals and their respective takes on oncologic drug development with Biocentury TV's Steve Usdin.

Dr. Paul Kluetz, a clinical reviewer for OHOP rejected the notion that OHOP incentives are aligned against the approval of products, saying that "there is no incentive to approve or not approve a drug."

Continued Kluetz, "really, our job is relatively simple in that we take the data and take the totality of the evidence that we're given and make the best decision on the benefit:risk for reach individual review."

"I think one of the things that distinguishes oncology from other areas are our major issues in reviewing applications - the demonstration of efficacy and how well these drugs work," added OHOP Director Richard Pazdur. "Oncology really has a different safety profile, and many of the safety issues that have been paramount in discussions with FDA [at large] really have not been germane to the oncology situation."

The OHOP panelists also sought to respond to critics who contend that OHOP has been overly focused on the risk of a product as opposed to its benefits.

"It really is our responsibility to ensure that a drug is effective," said Clinical Reviewer Dr. Tatiana Prowell. "Patients should demand it and we should supply that information."

Kluetz challenged the critique outright, saying that "most of the decisions that are difficult to make have more recently been with respect to benefit rather than risk."

Benefit:Risk Assessment

The OHOP reviewers said they need to make sure oncology drugs, which can cause significant toxicities, aren't being screened out of the process for being associated with toxicities that the cancer itself is causing, said Clinical Reviewer Dr. Marc Theoret. "You don't want to hinder the development of a potentially effective drug going forward," added Theoret.

"In the end, what we all want is safe and effective drugs to treat cancer," said Prowell. "Nearly one in two Americans get cancer, whether we work at FDA or whether we work for a [drug] company."

However, when it comes to proving the benefits of a drug, "the data is the data," said Pazdur.

Pazdur also thinks we would be better off if that data were made public. "I think it's unfortunate that the only way the public understands the rationale behind a negative decision against an approval is if the drug is presented at an advisory committee meeting," said Prowell. FDA is otherwise banned from disclosing the data or rationale behind its decision to not approve a product to the public.

Advisory Committees and Review Cohesion

The panelists also spoke to their interpretations of advisory committee meetings. Pazdur said that more than the vote totals, the rationale "behind why an individual was voting in a particular way" is most important to OHOP staff.

Prowell also spoke to the review cohesion of OHOP, saying that conflicts are "surprisingly rare."

"I'd say it's quite rare for Dr. Pazdur to overturn a decision by the primary review team, because those are the people who spend a lot of the time analyzing the data, and spend a great amount of time thinking about the risk benefit issues for a particular drug for months on end," said Prowell.

Regulatory Advice

The benefit of integrating regulatory strategy in to the development of products was also the topic of discussion.

"It's important to integrate the decision to use the accelerated approval pathway early in drug development so you know what your postmarketing trials are going to look like, what they're going to be designed like and, preferably, that they're under way at the time of accelerated approval," said Kluetz.

"Rather than a drug not making it, [the development is] just delayed because of a poor development plan," noted Kluetz. This hurts not only the company, but also patients who are denied potentially lifesaving treatments, added Prowell.

Early communication with FDA is extremely useful in determining how best to integrate regulatory strategy and drug development, said Prowell. Theoret went as far as to call poor communication the biggest mistake that applicants make when trying to get a drug product through OHOP, saying that some companies can waste valuable time chasing unnecessary endpoints or gathering the wrong data.